Cephea Early Feasibility Study

Mitral Regurgitation Clinical Trial

Official title:

Cephea Early Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061004
• Other study ID #: ABT-CIP-10354
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: June 1, 2029

Study information

• Verified date: January 2024
• Source: Abbott Medical Devices
• Contact: Shimako Nakajima
• Phone: +1 408-845-0873
• Email: shimako.nakajima[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2029
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Mitral valve disease resulting in mitral regurgitation (MR = Grade III) and/or severe mitral valve stenosis (mitral valve area = 1.5cm²) per American Society of Echocardiography criteria.

• LVEF = 30%

• In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.

Key Exclusion Criteria:

• Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.

• Need for emergent or urgent surgery.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Cephea Mitral Valve System
Transcatheter mitral valve replacement

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Montreal	Montreal	Quebec
Canada	Institut de Cardiologie de Quebec	Quebec
United States	University of Michigan	Ann Arbor	Michigan
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Methodist Hospital	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University of California - Davis Medical Center	Sacramento	California
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Freedom from all-cause mortality, which will be assessed at 30 days post implant.	30 days post implant
Primary	Primary Effectiveness Endpoint	Proportion of subjects with reduction of MR to = Grade I, will be assessed at 30 days post implant.	30 days post implant